CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 4 enrolled
Drug / intervention
Olympic Cool Capdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00620711
NCT00620711Phase 1Completed
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IRB# 070984 "Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy"

Vanderbilt University·interventional·Posted Feb 21, 2008·Updated Jan 29, 2019

In Brief

A Phase 1 clinical trial evaluating Olympic Cool Cap for Hypoxic Ischemic Encephalopathy. Completed, enrolled 4 participants across 1 site.

Detailed Summary

The hypothesis is that premature infants' can have enough cooling applied to cool their brain to decrease CNS injury without cooling their body.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypoxic Ischemic Encephalopathy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 21, 2008
Enrollment StartFeb 1, 2008
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 18.4 years ago

Interventions

Olympic Cool Capdevice

Olympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE.